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临床试验/NCT07094191
NCT07094191
已完成
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Comparative Acute Effects of Caffeine-Free Chicory and Arabica Coffee on Inflammatory and Metabolic Responses to Exercise in Healthy Men: A Randomized Crossover Trial

Fatma Özsel Özcan1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年1月1日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Fatma Özsel Özcan
入组人数
22
试验地点
1
主要终点
Plasma Lipoprotein Lipase (LPL) Level (ng/mL)

概览

简要总结

The goal of this clinical trial is to evaluate the acute effects of chicory coffee on metabolism and exercise performance in healthy, moderately active male participants aged 18-25. The main questions it aims to answer are:

Does chicory coffee influence glucose, lipid, and energy metabolism after exercise?

Does chicory coffee affect physical performance and perceived fatigue levels?

Researchers will compare chicory coffee (CC), arabica coffee (AC), and a no-drink control to see if chicory coffee has similar or unique metabolic and performance effects compared to caffeinated coffee or no intervention.

Participants will:

Consume one of the test beverages (chicory coffee, arabica coffee, or no drink) 45 minutes before performing a shuttle-run test

Complete a standardized shuttle-run exercise test

Undergo blood sample collection before and after exercise to assess glucose, lactate, LPL, TNF-α, adiponectin, and IL-6

Rate their perceived exertion and record symptoms

详细描述

This study used a single-blind, randomized, controlled crossover design involving 22 healthy, moderately active male participants aged 18-25. Each participant underwent three intervention conditions in a randomized order:

Chicory coffee (CC)

Arabica coffee (AC)

Control (no beverage)

Before each trial, baseline data-including health status, dietary habits, and body composition-were collected. Participants consumed the assigned beverage 45 minutes before performing a shuttle-run test designed to assess endurance and physical performance. A 3-day washout period separated each intervention session to eliminate carryover effects.

During each session, pre- and post-exercise measurements included:

Blood glucose, lactate, blood pressure, and oxygen saturation

Subjective fatigue assessed by the Borg Rating of Perceived Exertion (RPE)

Additionally, venous blood samples were collected after exercise and analyzed for key metabolic and inflammatory biomarkers:

Lipoprotein lipase (LPL)

Tumor necrosis factor-alpha (TNF-α)

Adiponectin

Interleukin-6 (IL-6)

All blood samples were processed under cold-chain conditions and analyzed using ELISA methods. Dietary intake was monitored, and participants were instructed to maintain their usual eating habits while avoiding other caffeinated beverages during the study period.

Statistical analysis included MANOVA and ANOVA, with Bonferroni corrections used for multiple comparisons.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male participants aged 18 to 25 years
  • Healthy status based on self-report and screening (no diagnosed chronic disease)
  • Moderately physically active (minimum 3 days/week of physical activity)
  • No regular use of medication or dietary supplements
  • No caffeine consumption for at least 7 days prior to and during the study
  • Willing and able to provide informed consent
  • Able to complete the shuttle-run test as instructed

排除标准

  • Diagnosed with metabolic, cardiovascular, or inflammatory disease
  • Regular caffeine use or caffeine withdrawal symptoms
  • Use of alcohol, stimulants, or performance-enhancing substances during the study
  • Known allergy or intolerance to chicory or coffee
  • Participation in another clinical study within the last 30 days
  • Any musculoskeletal or respiratory condition that prevents safe participation in exercise
  • Inability to comply with the dietary or testing protocol

结局指标

主要结局

Plasma Lipoprotein Lipase (LPL) Level (ng/mL)

时间窗: At baseline and within 10 minutes post-exercise

This outcome measures the concentration of plasma lipoprotein lipase (LPL) in ng/mL after completion of the shuttle run exercise protocol. Blood samples were collected post-exercise, and serum was analyzed to determine LPL levels using ELISA-based methods. This parameter reflects lipid metabolism activity in response to acute exercise under fasting conditions.

Tumor Necrosis Factor-alpha (TNF-α)

时间窗: At baseline and within 10 minutes post-exercise

This outcome measures the concentration of tumor necrosis factor-alpha (TNF-α) in serum samples collected after the shuttle run exercise protocol. TNF-α levels were analyzed using enzyme-linked immunosorbent assay (ELISA) techniques. TNF-α is a key pro-inflammatory cytokine, and its elevation post-exercise is indicative of acute inflammatory response and immune system activation.

This outcome measures blood lactate concentration in mmol/L to evaluate the metabolic response to shuttle run exercise. Capillary blood samples were taken from the fingertip at three time points: before, during, and immediately after exercise.

时间窗: At baseline (immediately before exercise), mid-exercise, and immediately after exercise

lactate measurement

Venous Blood Glucose Level

时间窗: At baseline (pre-exercise) and within 10 minutes post-exercise

This outcome measures venous blood glucose concentration (mg/dL) after completion of the shuttle run exercise protocol. Blood samples were collected from finger. Post-exercise glucose levels provide insight into glycemic regulation, insulin sensitivity, and metabolic response under fasting and exertional conditions.

Systolic and diastolic blood pressure

时间窗: Systolic and diastolic blood pressure measured immediately before and immediately after exercise

This outcome measures systolic and diastolic blood pressure (mmHg) to evaluate acute cardiovascular response to exercise. Measurements were taken at rest and immediately after the shuttle run using a digital sphygmomanometer.

Subjective Fatigue Score (Borg Scale)

时间窗: Immediately after completion of the shuttle run exercise protocol

This outcome assesses perceived fatigue using the Borg Rating of Perceived Exertion (RPE) Scale immediately following the shuttle run exercise. Participants rated their level of physical exertion on a scale from 6 (no exertion at all) to 20 (maximal exertion). The Borg Scale is a validated tool for evaluating subjective fatigue and exercise intensity.

Adiponectin

时间窗: At baseline and within 10 minutes post-exercise

This outcome measures the concentration of adiponectin in serum samples collected after the shuttle run exercise protocol. Serum adiponectin levels were determined using enzyme-linked immunosorbent assay (ELISA) methods. Adiponectin is an anti-inflammatory adipokine involved in glucose regulation and lipid metabolism, and its measurement provides insight into the metabolic response to acute exercise.

Interleukin-6 (IL-6)

时间窗: At baseline and within 10 minutes post-exercise

This outcome measures the concentration of interleukin-6 (IL-6) in serum samples collected after the shuttle run exercise protocol. IL-6 levels were determined using an enzyme-linked immunosorbent assay (ELISA). IL-6 is a pro-inflammatory cytokine known to respond acutely to physical exertion and is used as a biomarker of systemic inflammation and exercise-induced stress.

次要结局

  • Oxygen saturation(At baseline (immediately before exercise), mid-exercise, and immediately after exercise)

研究者

发起方
Fatma Özsel Özcan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatma Özsel Özcan

Assistant Professor

Halic University

研究点 (1)

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